Formulation and Analytical Challenges in Development of Fixed-Dose Combination Products for Biologics

Dr. Zhi Chen is an Associate Scientific Director in the department of Sterile Product Development in Bristol Myers Squibb. He and his team are responsible for developing analytical methods and strategies to support formulation development, drug product process development and CQA assessment. Dr. Chen has been a key contributor to many IND and BLA filings. Prior to joining BMS, Dr. Chen’s career spanned in Merck, Novartis, and legacy Schering-Plough. He has been a significant contributor to the commercialization of many marketed products including Keytruda®, Opdivo®, and Opdualag™.